11.100 : Laboratory medicine

11.100.01

Laboratory medicine in general

11.100.10

In vitro diagnostic test systems

11.100.20

Biological evaluation of medical devices

11.100.30

Analysis of blood and urine

11.100.99

Other standards related to laboratory medicine
UNE-EN ISO 10993-4:2009

UNE-EN ISO 10993-4:2009

Superseded Historical

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

€92.00

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UNE-EN ISO 10993-6:2009

UNE-EN ISO 10993-6:2009

Superseded Historical

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

€75.00

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UNE-EN ISO 10993-9:2009

UNE-EN ISO 10993-9:2009

Superseded Historical

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

€62.00

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UNE-EN ISO 18113-5:2010

UNE-EN ISO 18113-5:2010

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

€61.00

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UNE-EN ISO 18113-3:2010

UNE-EN ISO 18113-3:2010

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

€62.00

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UNE-EN ISO 10993-10:2009 ERRATUM:2010

UNE-EN ISO 10993-10:2009 ERRATUM:2010

Withdrawn Most Recent

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

€0.00

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UNE-EN ISO 10993-10:2011

UNE-EN ISO 10993-10:2011

Superseded Historical

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

€127.00

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UNE-EN ISO 23640:2012

UNE-EN ISO 23640:2012

Superseded Historical

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

€59.00

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UNE-EN ISO 23640:2013

UNE-EN ISO 23640:2013

Superseded Historical

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

€59.00

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UNE-EN ISO 10993-4:2017

UNE-EN ISO 10993-4:2017

Superseded Historical

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

€131.00

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UNE-EN 30993-1:1994

UNE-EN 30993-1:1994

Superseded Historical

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 1: GUIDANCE ON SELECTION OF TESTS. (ISO 10993-1:1992)

€64.00

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UNE-EN 12286/A1:2000

UNE-EN 12286/A1:2000

Superseded Historical

IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.

€26.00

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UNE-EN 591:2001

UNE-EN 591:2001

Superseded Historical

Instructions for use for in vitro diagnostic instruments for professional use.

€60.00

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UNE-EN ISO 10993-14:2002

UNE-EN ISO 10993-14:2002

Superseded Historical

Biological evaluation of medical devices. Part 14: Identification and quantification of degradation products from ceramics. (ISO 10993-14:2001)

€69.00

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UNE-EN 376:2002

UNE-EN 376:2002

Superseded Historical

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing.

€62.00

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